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Ezetimibe for Patients With Chronic Hepatitis D

Primary Purpose

Chronic Hepatitis D

Status
Unknown status
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Ezetimibe
Sponsored by
Ziauddin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis D focused on measuring hepatitis D, Ezetimibe, HDV RNA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy
  • Age 18 years or above
  • Presence of anti-HDV in serum
  • Presence of quantifiable HDV RNA in serum
  • Elevated ALT > ULN

Exclusion Criteria:

  • Decompensated liver disease
  • Patients with ALT levels greater than 10 times ULN (400 U/L)
  • Pregnancy or inability to practice adequate contraception.
  • Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease.
  • Systemic immunosuppressive therapy
  • Evidence of another form of liver disease in addition to viral hepatitis
  • Active substance abuse, such as alcohol or injection drugs
  • Hepatocellular carcinoma
  • Concurrent hepatitis C infection or HIV coinfection
  • Diagnosis of malignancy in the five years
  • Concurrent usage of statins
  • Concurrent use of any other drug known to inhibit NTCP
  • Inability to understand or sign informed consent
  • Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study

Sites / Locations

  • Ziauddin University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ezetimibe

Arm Description

Outcomes

Primary Outcome Measures

• Decline of HDV RNA quantitative measurements of >1 logs from baseline

Secondary Outcome Measures

Full Information

First Posted
March 28, 2017
Last Updated
March 28, 2017
Sponsor
Ziauddin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03099278
Brief Title
Ezetimibe for Patients With Chronic Hepatitis D
Official Title
Ezetimibe for Patients With Chronic Hepatitis D
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Ezetimibe possesses pharmacophore features to inhibit NTCP, the receptor required for HBV and HDV hepatocyte entry that include two hydrophobes and one hydrogen bond acceptor. Therapy with Ezetimibe may lead to decline in hepatitis D virus levels. The aim of the study is to evaluate the utility of Ezetimibe in patients with chronic HDV infection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis D
Keywords
hepatitis D, Ezetimibe, HDV RNA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ezetimibe
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
Ezetimibe 20 mg oral daily
Primary Outcome Measure Information:
Title
• Decline of HDV RNA quantitative measurements of >1 logs from baseline
Time Frame
12 weeks of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Treatment experienced patients; non-responders of relapsers of pegylated interferon therapy Age 18 years or above Presence of anti-HDV in serum Presence of quantifiable HDV RNA in serum Elevated ALT > ULN Exclusion Criteria: Decompensated liver disease Patients with ALT levels greater than 10 times ULN (400 U/L) Pregnancy or inability to practice adequate contraception. Significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (eGFR<50 ml/min), organ transplantation, serious psychiatric disease or depression and active coronary artery disease. Systemic immunosuppressive therapy Evidence of another form of liver disease in addition to viral hepatitis Active substance abuse, such as alcohol or injection drugs Hepatocellular carcinoma Concurrent hepatitis C infection or HIV coinfection Diagnosis of malignancy in the five years Concurrent usage of statins Concurrent use of any other drug known to inhibit NTCP Inability to understand or sign informed consent Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zaigham Abbas
Phone
922135862937
Email
drzabbas@gmail.com
Facility Information:
Facility Name
Ziauddin University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaigham Abbas

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ezetimibe for Patients With Chronic Hepatitis D

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